Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).

Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series [ Time Frame: one month after 3-dose infant series (at 7 months of age) ]

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)=number of participants with a determinate postinfant series IgG antibody concentration to the given serotype.

Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).

Measured Values

13vPnC

7vPnC

Number of Participants Analyzed
[units: participants]

94

108

Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
[units: percentage of participants]Number ( 95% Confidence Interval )

Common Serotypes - Serotype 4 (n=94,107)

96.81
( 90.96 to 99.34 )

99.07
( 94.90 to 99.98 )

Common Serotypes - Serotype 6B (n=94,107)

88.30
( 80.03 to 94.01 )

88.79
( 81.23 to 94.07 )

Common Serotypes - Serotype 9V (n=94,108)

96.81
( 90.96 to 99.34 )

99.07
( 94.95 to 99.98 )

Common Serotypes - Serotype 14 (n=94,107)

97.87
( 92.52 to 99.74 )

97.20
( 92.02 to 99.42 )

Common Serotypes - Serotype 18C (n=94,106)

96.81
( 90.96 to 99.34 )

99.06
( 94.86 to 99.98 )

Common Serotypes - Serotype 19F (n=94,106)

97.87
( 92.52 to 99.74 )

97.17
( 91.95 to 99.41 )

Common Serotypes - Serotype 23F (n=94,108)

94.68
( 88.02 to 98.25 )

95.37
( 89.53 to 98.48 )

Additional Serotypes - Serotype 1 (n=94,108)

97.87
( 92.52 to 99.74 )

25.00
( 17.17 to 34.25 )

Additional Serotypes - Serotype 3 (n=94,107)

98.94
( 94.21 to 99.97 )

14.02
( 8.06 to 22.07 )

Additional Serotypes - Serotype 5 (n=93,107)

100.00
( 96.11 to 100.00 )

42.06
( 32.58 to 51.99 )

Additional Serotypes - Serotype 6A (n=93,106)

96.77
( 90.86 to 99.33 )

33.96
( 25.04 to 43.80 )

Additional Serotypes - Serotype 7F (n=94,105)

98.94
( 94.21 to 99.97 )

6.67
( 2.72 to 13.25 )

Additional Serotypes - Serotype 19A (n=94,107)

100.00
( 96.15 to 100.00 )

94.39
( 88.19 to 97.91 )

Statistical Analysis 1 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

Groups [1]

All groups

Difference [2]

-2.26

95% Confidence Interval

( -8.08 to 2.33 )

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated

[2]

Other relevant estimation information:

No text entered.

Statistical Analysis 2 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

Groups [1]

All groups

Difference [2]

-0.49

95% Confidence Interval

( -9.93 to 8.65 )

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated

[2]

Other relevant estimation information:

No text entered.

Statistical Analysis 3 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

Groups [1]

All groups

Difference [2]

-2.27

95% Confidence Interval

( -8.07 to 2.26 )

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated

[2]

Other relevant estimation information:

No text entered.

Statistical Analysis 4 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

Groups [1]

All groups

Difference [2]

0.68

95% Confidence Interval

( -4.96 to 6.16 )

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated

[2]

Other relevant estimation information:

No text entered.

Statistical Analysis 5 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

Groups [1]

All groups

Difference [2]

-2.25

95% Confidence Interval

( -8.18 to 2.36 )

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated

[2]

Other relevant estimation information:

No text entered.

Statistical Analysis 6 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

Groups [1]

All groups

Difference [2]

0.70

95% Confidence Interval

( -4.84 to 6.32 )

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated

[2]

Other relevant estimation information:

No text entered.

Statistical Analysis 7 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

Groups [1]

All groups

Difference [2]

-0.69

95% Confidence Interval

( -7.75 to 5.86 )

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated

[2]

Other relevant estimation information:

No text entered.

Statistical Analysis 8 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

Groups [1]

All groups

Difference [2]

72.87

95% Confidence Interval

( 63.32 to 81.07 )

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated

[2]

Other relevant estimation information:

No text entered.

Statistical Analysis 9 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

Groups [1]

All groups

Difference [2]

84.92

95% Confidence Interval

( 76.73 to 91.05 )

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated

[2]

Other relevant estimation information:

No text entered.

Statistical Analysis 10 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

Groups [1]

All groups

Difference [2]

57.94

95% Confidence Interval

( 48.01 to 67.42 )

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated

[2]

Other relevant estimation information:

No text entered.

Statistical Analysis 11 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

Groups [1]

All groups

Difference [2]

62.81

95% Confidence Interval

( 52.33 to 72.20 )

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated

[2]

Other relevant estimation information:

No text entered.

Statistical Analysis 12 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

Groups [1]

All groups

Difference [2]

92.27

95% Confidence Interval

( 85.26 to 96.54 )

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated

[2]

Other relevant estimation information:

No text entered.

Statistical Analysis 13 for Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

Groups [1]

All groups

Difference [2]

5.61

95% Confidence Interval

( 1.23 to 11.86 )

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated

[2]

Other relevant estimation information:

No text entered.

4. Secondary:

Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose [ Time Frame: One month after the toddler dose (at 13 to 16 months of age) ]

Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose [ Time Frame: Immediately before (12 to 15 months of age) and one month after the toddler dose (13 to 16 months of age) ]

Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series [ Time Frame: One month after the infant series (7 months of age) ]

Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series [ Time Frame: one month after the infant series (7 months of age) ]

Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series [ Time Frame: one month after the infant series (7 months of age) ]

Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series [ Time Frame: one month after the infant series (7 months of age) ]